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A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty

Primary Purpose

Unilateral Primary Osteoarthritis, Unspecified Hip

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monocryl closure
Vicryl and Staple closure
Tegaderm dressing
Gauze dressing
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Primary Osteoarthritis, Unspecified Hip focused on measuring Suture, Skin staples, Vicryl, Monocryl

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18 - 100 years old
  2. Undergoing total hip replacement

Exclusion Criteria:

  1. Previous scar over newly planned incision
  2. Alcoholism
  3. Mentally unfit to complete questionnaire
  4. Connective tissue disease and/or psoriasis/eczema/dermatitis
  5. Previous joint infection at surgical site
  6. Any use of immunosuppressive medications or disease modifying agents
  7. Medical contra-indication to surgery
  8. Pregnancy
  9. Lack of permanent home address
  10. Drug Abuse
  11. Allergy to Skin Adhesive

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Monocryl closure

    Vicryl and staple closure

    Arm Description

    The skin incision is closed with monocryl dissolvable sutures and a topical adhesive (glue) called Dermabond and covered with a Tegaderm dressing. Intervention: Monocryl closure, Tegaderm dressing

    The skin incision is closed with vicryl and staples and covered with a gauze dressing. Intervention: Vicryl and Staple closure, Gauze dressing

    Outcomes

    Primary Outcome Measures

    Patient Observer Scar Assessment Scale for overall patient satisfaction rates.
    Questionnaire

    Secondary Outcome Measures

    Wound complications
    Analysis - number of participants with wound complications
    Drainage rates
    Analysis - number of participants with wound drainage
    Need for post-operative antibiotics
    Analysis - number of participants with need for post-operative antibiotics
    Patient pain score
    Questionnaire

    Full Information

    First Posted
    May 28, 2015
    Last Updated
    August 6, 2015
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02519829
    Brief Title
    A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
    Official Title
    A Randomized Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients undergoing primary hip arthroplasty will be randomized to receive either monocryl closure of fascial and dermal layers with dermabond and tegaderm covering versus standard vicryl closure of fascia layer and staple closure for skin. Short term wound complications, pain and patient and surgeon-rated cosmetic scar appearance will be measured. The investigators will also measure operating room time and costs associated with dressing changes and wound-related procedures (e.g. staple removal).
    Detailed Description
    Wound closure has always been based on surgeon preference and type of closure. Skin closure is considered the most important part of the surgical procedure by some since it is often the only visible evidence of the surgical procedure. In fact, conclusions about the success of the surgery are often based on the appearance of the wound. There have been a few studies in a variety of surgical journals that have looked at the two pertinent methods of closure with the majority coming from obstetrical journals comparing caesarian section closure with staples versus a subcuticular monocryl suture. For the most part, although patient satisfaction is quite high initially for a subcuticular closure, at long term follow-up patient satisfaction scores are quite similar. One study published in the Journal of Bone and Joint Surgery recommended that staple closure was more beneficial for skin closure than monocryl sutures for total hip and knee arthroplasty. Their recommendations were based on an overall shorter operative time when using staple closure compared to monocryl sutures. They also found that final patient satisfaction and complication rates were relatively similar 3 months postoperatively. This group published an earlier paper as well describing the use of glue for closure and did report an decrease in overall drainage rates when they analyzed their data for subcuticular sutures as opposed to staples. A more recent study evaluated wound appearance at 3 months using a surgeon -rated visual analogue scale to compared the use of adhesive tapes versus staples for skin closure following total hip arthroplasty. Again, no significant difference in patient satisfaction scores were reported. To date, there is a paucity of well-powered studies to compare outcomes in patients whose wounds are closed using the usual staple methods compared to a monocryl suture method. In addition, outcomes have focused on surgeon-ratings and not patient ratings. The proposal for this study is to compare overall patient and surgeon-rated cosmetic scar appearance and complications following total hip replacement with skin closure for using monocryl suture versus staples. This study would use a more recent, validated assessment tool than the VAS scale. The assessment is called the Patient Observer Scar Assessment Scale (POSAS ) and it incorporates six essential features about the wound such as colour, malleability, etc. The form is split so that the surgeon rating carries the same weight in the final score as the patient assessment of their own scar. This scale gives a nice balance for determining overall satisfaction and wound healing combining surgeon and patient scores.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Unilateral Primary Osteoarthritis, Unspecified Hip
    Keywords
    Suture, Skin staples, Vicryl, Monocryl

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    139 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Monocryl closure
    Arm Type
    Active Comparator
    Arm Description
    The skin incision is closed with monocryl dissolvable sutures and a topical adhesive (glue) called Dermabond and covered with a Tegaderm dressing. Intervention: Monocryl closure, Tegaderm dressing
    Arm Title
    Vicryl and staple closure
    Arm Type
    Active Comparator
    Arm Description
    The skin incision is closed with vicryl and staples and covered with a gauze dressing. Intervention: Vicryl and Staple closure, Gauze dressing
    Intervention Type
    Procedure
    Intervention Name(s)
    Monocryl closure
    Intervention Description
    Total Hip Arthroplasty with monocryl closure of wound
    Intervention Type
    Procedure
    Intervention Name(s)
    Vicryl and Staple closure
    Intervention Description
    Total Hip Arthroplasty with vicryl and staple closure of wound
    Intervention Type
    Procedure
    Intervention Name(s)
    Tegaderm dressing
    Intervention Description
    Total Hip Arthroplasty with monocryl closure of wound and tegaderm dressing
    Intervention Type
    Procedure
    Intervention Name(s)
    Gauze dressing
    Intervention Description
    Total Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing
    Primary Outcome Measure Information:
    Title
    Patient Observer Scar Assessment Scale for overall patient satisfaction rates.
    Description
    Questionnaire
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Wound complications
    Description
    Analysis - number of participants with wound complications
    Time Frame
    2 week, 6 week, 3 month post-operatively
    Title
    Drainage rates
    Description
    Analysis - number of participants with wound drainage
    Time Frame
    2 week, 6 week, 3 month post-operatively
    Title
    Need for post-operative antibiotics
    Description
    Analysis - number of participants with need for post-operative antibiotics
    Time Frame
    2 week, 6 week, 3 month post-operatively
    Title
    Patient pain score
    Description
    Questionnaire
    Time Frame
    2 week, 6 week, 3 month post-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 - 100 years old Undergoing total hip replacement Exclusion Criteria: Previous scar over newly planned incision Alcoholism Mentally unfit to complete questionnaire Connective tissue disease and/or psoriasis/eczema/dermatitis Previous joint infection at surgical site Any use of immunosuppressive medications or disease modifying agents Medical contra-indication to surgery Pregnancy Lack of permanent home address Drug Abuse Allergy to Skin Adhesive
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James L Howard, MD
    Organizational Affiliation
    London Health Sciences Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty

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